Fluoroquinolone Community Goes to the FDA

On April 23th, 2015, a group from within the Fluoroquinolone community, consisting of Terry Aston, John Fratti, Linda Martin, David Melvin, and Alan Redd, held a conference with Officials from the FDA to push for mitochondrial warnings to be placed on Fluoroquinolone labels.

The FQ members met with the FDA as a concerned group of private citizens, not sponsored by any organization or entity.

Our group was invited by the FDA to present our arguments to a panel of FDA Officials that included a Medical Doctor, Pharmacist, and other agency Officials. During the hour long meeting, the group presented information that included, but was not limited to:

The reported and projected number of adverse events, including death outcomes, from three major Fluoroquinolones, based on data from the FDA Medwatch system.

The shocking number of off-label pediatric prescriptions of Levaquin.

Data from the FDA’s own internal Pharmacovigilance Review concluding that a mitochondrial toxicity was a possible cause of patient damage from the Fluoroquinolones.

The FDA’s failure to act properly on its own internal research and findings.

The tremendous health care burden that the Fluoroquinolones are creating or exacerbating in regards to health care costs, long term suffering and generational genetic damage.

The FDA’s legal responsibility to act in the best interest of public safety.

The increasing media coverage about the Fluoroquinolones.

And more…

The FDA was encouraged to work in conjunction with the Fluoroquinolone community, to act on the Citizen’s Petitions submitted to the FDA by Dr. Charles Bennett and SONAR in June 2014, and to immediately place wording consistent with the Citizen’s Petition about mitochondrial warnings on the Fluoroquinolone label. The significant number of lives that could be saved by acting immediately was stressed several throughout the conference.

Legal restrictions prohibited the FDA from openly discussion the current Citizen Petitions concerning Fluoroquinolones, however, there were no limits placed on the scope of our presentation to the FDA.

The FDA’s Medical Doctor, present at the meeting, stated that this was the most compelling and comprehensive presentation they have seen by a group of patients. The FDA Officials were also moved by the stories of suffering experienced by the myriad of Fluoroquinolone victims, in addition to the individual stories compiled in the FQ DC Rally Story Book 2014 that was presented to the FDA Officials before the conference.

We believe that this meeting, in addition to the extensive media attention, offers the best hope for action by the FDA on Fluoroquinolones to date.

Our presentation and our call to action to the FDA is now part of the official government record. We will be watching closely for the FDA’s response. We are currently working on further plans to insure consistent attention and pressure be brought to bear on this extremely important issue with the FDA.

Stayed tuned to My Quin story for timely updates on our interactions with the FDA, Dr. Bennett and the Citizen Petition, and community related research.